Search Jobs: Results: Senior Quality Engineer - Medical Device Design Control and Product Development
Multiple Design control quality engineer opportunities have been created to keep pace with active product launches in multiple divisions of this medical device leader known for focus on their employees professional development.
The Challenges:
1) Partner with R&D, Manufacturing, Engineering and Regulatory experts to design and launch new Class II Medical Devices while concurrently working on process improvements in existing products.
2) You will focus on process validation, design validation, process capability issues and Quality Systems implementations and, from your findings, define and implement CAPA’s so as to lead operational improvements.
3) As you further grow your design control, design history and design review skills you will perform statistical and risk analysis, process validations and develop sample plans
Salary: Base will be DOE (80’s to near 100k) and will include excellent bonus, benefits, incentive compensation, relocation and stability.
Location: New Jersey
Contact: Apply below and/or contact Ira Mann at iram@fpccareers.com
Qualifications:
While a BS degree (Engineering preferred) and 4+ years of Medical Device Quality experience is required, MOST IMPORTANT is to highlight either on your resume, addendum or cover letter your experience with:
1) Design controls (and/or design validation, design reviews and/or design history file management) in a medical device product development environment
Experience with the following also preferred:
- Statistical analysis / SPC
- Opening and closing CAPA’s
- Process validation, design validation and test method validation.
- Statistical analysis, process development and sample plan development
- Product and process improvements
- Health Hazard Analysis
- Reliability, shelf life, sterilization and biocompatibility studies
- Risk Analysis, Risk Management and FMEA
- Quality assurance training
- Quality Audits including FDA, Notified Body or customer
- Certification as a Six Sigma Green Belt or Black Belt desired
- Team leadership and project management skills
Job Details
| Name: | Ira Mann | Date Posted: | 7/02/2010 |
| Office: | Atlanta | Telephone: | (770) 246-9757 |
| Email: | iram@fpccareers.com | Fax: | |
| Category: | Medical Device, Product Development, Quality Engineer | ||
| Keywords: | design control, design review, design history file, CAPA, SPC, statistics, process validation, injection molding, catheter, syringe, injector, design validation, product development, improvement, biocompatibility, Six Sigma, reliability, sample plan development, Health Hazard Analysis | Region: | |
| State: | NJ | City: | |
| Education: | BS | Job Number: | J31289-ATLA-15208-IM |
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